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Summary Information Format for the Importation of 

Veterinary Biological Products into the United States 

I. INTRODUCTION

The purpose of this Summary Information Format (SIF) is to provide the USDA-APHIS Center for 

Veterinary Biologics (CVB) with the necessary information to conduct a risk analysis for proposals to 

import unlicensed veterinary biological products into the United States, as described in 9 CFR 104. 

This includes proposals to import complete veterinary biological products licensed in other countries, 

experimental veterinary biologics in either final or bulk form, CVB-approved master seeds, CVBapproved master cells or diagnostic kits. Other forms of biologics will be considered, however 

cultures of microorganisms other than master seeds, cells other than master cells, recombinant 

material, animal products, human biologics, human diagnostic kits or other materials for research 

studies are typically not considered a veterinary biologic for importation purposes. 

This SIF may be requested to support an import from any country, with special emphasis on imports 

from: 1) countries where foreign animal diseases or other diseases of concern exist, or 2) other 

specified countries that supplement their national meat supply by the importation of fresh, chilled, or 

frozen meat of ruminants or swine from, or 3) have common land borders with countries where 

foreign animal diseases exist, as provided in 9 CFR Part 94.

Completion of Section II is always required. Sections III and IV might be required based on the 

type of import request and guidance from CVB. Items that are not applicable should be marked 

as such.

II. PRIMARY INFORMATION

A. Characteristics of the imported biological material

1. Provide a thorough description of the product (product literature and 

publications should be attached as supplementary information):

2. If applicable, describe any live/viable components:

3. If applicable, describe any recombinant/genetically modified components:

4. If applicable, describe any inactivation methods and confirmatory testing:

5. If applicable, describe any extraneous agent or purity testing:
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(a) If final product has not been tested, list testing conducted on all

components:

(b) List any other testing or inactivation information relative to components 

in the product that should be considered when evaluating the risk of 

possible contamination of this product with extraneous micro-organisms 

or prions:

6. If applicable, indicate any product licensure in other countries:

B. Sources of materials 

1. Country from which the biological product will be imported:

2. List other countries the biological product or components were developed in, 

originated from, or passed through:

3. List all ingredients of animal origin used in the development and production, and 

their sources:

4. List all other microorganisms in the production facility:

C. Describe the use of the material in the US

1. Location and biosafety level where the material will be stored and used:

2. Summary of the intended use (a detailed protocol should be attached as 

supplementary information for any products that will be used in animals, 

authorization from the State Veterinarian may also be required):

3. Handling and disposal of unused imported material, study waste, and carcasses 

(if applicable):
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4. Are there similar/alternative products available in the US? If so, indicate why 

importation is still necessary. NOTE: Importation of unlicensed products with 

US sourced and licensed alternatives will require extensive justification.

III. SUPPLEMENTARY INFORMATION

This section is only required for permits for sale and distribution, or if requested by CVB after initial 

submission of the information above.

A. Production history of each biological component. This could include a vaccine

microorganism, cell line, antibody, nucleic acid, diagnostic material, or other biological 

component. Provide this information for each component. Indicate if the component is a 

Master Cell or Master Seed as described in 9 CFR 101.6 and 101.7, respectively.

1. Identity and source of each microorganism or biological component:

2. Procedures used in the identification and purification of the biological 

component:

3. Procedures used to attenuate or genetically modify the biological component:

4. Procedures used for purity and extraneous agent testing, including the ability of 

testing procedures for detecting potential contaminating agents exotic to the

U.S.:

B. Ingredients of animal origin (e.g. cells, serum, etc) used at any step of development or 

production. Provide the following information for each:

1. Indicate steps in which these ingredients were used:
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2. Describe validation of testing procedures used to determine the absence of 

extraneous agents in each ingredient of animal origin prior to use:

3. Describe validation of treatment procedures to inactivate (or eliminate) 

extraneous agents in each ingredient of animal origin prior to use:

4. Methods used to verify accurate geographical origin of source materials:

C. Production media and any preservatives or additives used in production

1. Identity and source:

2. Quality control and/or sterilization procedures:

3. Purity testing:

D. Final product purity testing, including the sensitivity of testing procedures for potential 

contaminating agents exotic to the U.S.:

E. Packaging, labeling, and storage conditions for the final container samples:

F. Proposed shipping procedures and conditions:

IV. FACILITIES INFORMATION

This section is only required for permits for sale and distribution, or if requested by CVB after initial 

submission of the information above.

A. For each organism (master seed), cell (master cell), diagnostic kit material or other 

biological component:

1. Research/Development Facility: (if multiple components/locations, include the 

information for each)
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(a) Location address:

(b) Description of activity:

(c) Biocontainment:

(i) Air-handling system:

(ii) Containment equipment (eg: biosafety cabinets):

(iii) Operational, validated procedures:

2. Production Step Facility: (if multiple components/locations, include the 

information for each)

(a) Location address:

(b) Description of activity:

(c) Facilities documents, one copy – see reference 9 CFR Part 108 and 

Veterinary Services Memorandum 800.78:

(d) List of functions performed in each area and validated cleaning 

procedures in place to protect against contamination:

(e) List validated biocontainment practices used to protect against crosscontamination:

(f) List of equipment used:

(i) Validated cleaning, sanitation and sterilization processes in place:

(ii) Calibration of equipment to determine if in proper working order: